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ACTIVE NOT RECRUITING
NCT04381689
PHASE3

Phase 3 Study to Evaluate the Immunogenicity and Safety of Inactived Split Influenza Vaccine in Healthy Korea Infants

Sponsor: Il-Yang Pharm. Co., Ltd.

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety and immunogenicity of IL-YANG Inactivated Split Influenza Vaccine (IL-YANG Quadrivalent Seasonal Influenza Vaccine) in healthy infants from 6 months to under 3 years of age(≥ 6 months and \< 3 years)

Official title: Phase Ⅲ, Randomized, Double-blind, Active Controlled to Evaluate the Immunogenicity and Safety of "IL-YANG Quadrivalent Seasonal Influenza Vaccine" in Healthy Infants From 6 Months to Under 3 Years of Age(≥ 6 Months and < 3 Years)

Key Details

Gender

All

Age Range

6 Months - 3 Years

Study Type

INTERVENTIONAL

Enrollment

245

Start Date

2024-10-23

Completion Date

2026-05-31

Last Updated

2026-03-25

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

IL-YANG FLU Vaccine Prefilled Syringe INJ.

Teratect Prefilled Syringe Inj. 0.5mL

BIOLOGICAL

Fluarix Tetra Pre-filled Syringe

Fluarix Tetra Pre-filled Syringe 0.5mL

Locations (2)

Korea University ANSAN Hospital

Ansan-si, Gyeonnggi-do, South Korea

The Catholic University of Korea, Bucheon St. Mary's Hospital

Bucheon-si, Gyeonnggi-do, South Korea